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The FDA is poised to authorize a booster dose of the Pfizer/BioNTech or Moderna COVID-19 vaccines for immunocompromised people as soon as today. Read More
The FDA has issued a Complete Response Letter to San Francisco biotech FibroGen for roxadustat, its investigational drug for anemia linked to chronic kidney disease (CKD), calling for an additional clinical study before the agency will consider approving the drug. Read More
The cap on attorney contingency fees is meant to ensure that “an appropriate share of the money intended for abatement of the opioid crisis is actually used for that purpose,” wrote U.S. District Judge Dan Polster. Read More
Many oncologists who penned a February letter to President Biden endorsing Janet Woodcock’s nomination as permanent FDA commissioner received significant payments from drugmakers, a new analysis by researchers at Georgetown University reveals. Read More
The FDA is targeting unapproved drug products that are used for prevention or treatment of COVID-19 infections and has issued at least seven warning letters since early July, for three nasal or oral sprays, two hand sanitizers and two other drugs. Read More
The former director of NIH’s Biomedical Advanced Research and Development Authority (BARDA), Rick Bright, has settled his whistleblower complaint that he was retaliated against by HHS for pushing for a more robust response in the early days of the COVID-19 pandemic. Read More
Moderna’s COVID-19 vaccine may be more effective than the Pfizer-BioNTech vaccine at protecting against variants of the coronavirus that causes COVID-19, two “preprint,” nonpeer-reviewed studies suggest. Read More
“Based on the totality of the data we have for eprenetapopt, we believe that it continues to be a promising therapeutic option for cancer patients,” said Christian S. Schade, chairman and CEO of Aprea. Read More
The COVID-19 pandemic has spurred the World Health Organization (WHO) to release new draft guidelines on good manufacturing practices (GMPs) for investigational therapeutics. Read More
Axsome Therapeutics has received a deficiency letter from the FDA for its investigational neurological drug AXS-05 (dextromethorphan-bupropion) for major depressive disorder. Read More